Apollo Duet ADP-4000
Apollo Duet ADP-4000 is a radio-frequency physical therapy system (FDA Class II; FDA product code PBX, Massager, Vacuum, Radio Frequency Induced Heat) made by Weero Co., Ltd., cleared under FDA 510(k) K212253 on 25 Aug 2022 and listed in FDA GUDID since 13 Mar 2023 (UDI-DI 08809851470015), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number08809851470015 | Date13 Mar 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK212253 | Date25 Aug 2022 | StatusActive |
Official records
- AccessGUDID record 08809851470015
- FDA 510(k) database K212253
Across registries
- FDA 510(k) K212253 decided 25 Aug 2022 Active
- FDA GUDID UDI-DI 08809851470015 listed 13 Mar 2023 Listed
Timeline
- Cleared FDA 510(k) K212253
- Listed FDA GUDID 08809851470015
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Apollo Duet
- Generic name
- Radio-frequency physical therapy system
- Model / reference
- ADP-4000
- Primary DI / UDI-DI
- 08809851470015
- 510(k) Number
- FDA product code
- PBX
- GMDN term
- Radio-frequency physical therapy system
- Device class
- Class II
- Regulation number
- 878.4400
- GUDID distribution status
- In Commercial Distribution
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